After recommendation from the Advisory Board, the drug candidate will now be further assessed as a potential first-line therapy in advanced pancreatic cancer patients in a phase 2b trial.
BPGbio have submitted their findings for presentation to a major cancer meeting in January 2024.
In the phase 2a clinical trial, BPM 31510 IV demonstrated a tolerable safety profile in advanced refractory pancreatic cancer patients with an early indication for potential clinical benefit.
Prior to commencement of the phase 2a trial, the mechanism of action of BPM 31510 was first validated by data from BPGbio’s NAi Interrogative Biology multi omics AI platform.
The platform suggested that there is a hallmark shift in the tumor microenvironment (TME) wherein a Warburg shift is induced by BPM 31510 to modulate mitochondrial oxidative phosphorylation in highly aggressive tumors, with a direct effect on the BCL-2 protein family.
Niven R. Narain, CEO and president of BPGbio, said: “We are extremely encouraged to observe that BPM31510 has demonstrated an early indication of potential clinical benefit for patients with advanced refractory pancreatic cancer. Pancreatic cancer is the fourth leading cause of death of all cancers with only a 10% survival rate, we are focused on assessing further development of this drug for patients and their families affected by this devastating disease.”
Madappa Kundranda, chief of division of cancer medicine at Banner MD Anderson Cancer Center, added: “Advanced pancreatic cancer patients have limited treatment options and lack of early detection often leads to advanced diagnosis in most cases, resulting in devastating impacts on the family unit. Early indication from BPM31510 data, which targets the tumor microenvironment (TME) thus far supports further study in late-stage trials with the goal of offering hope for more effective treatment for the pancreatic patient community."
In addition, BPGbio has identified biomarkers for early disease diagnoses in pancreatic cancer through Project Survival, a 7-year study led in collaboration with Beth Israel Medical Center/Harvard Medical School, amongst others. According to the company, this initiative holds the promise of earlier disease diagnoses which may result in better outcomes, thereby potentially saving more lives.